Kornimate/medical-research-clean huggingface dataset:
feasibility of botox injection on improving female stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: the purpose of this study is to assess the effect of onabotulinumtoxin a (botox) injection into the detrusor muscle on increasing bladder compliance to reduce urinary leakage in women suffering from stress urinary incontinence (sui).

the study involves a single-time injection of 100 units of onabotulinumtoxin a into the detrusor muscle of the bladder. cystoscopy, which is the insertion of a scope with a small camera inside a tube into the participant's urethra. then the doctor fills the participant's bladder with water or saline and sees detailed images of the injection site in the bladder while administrating the injection.

Eligibility criteria:
inclusion criteria: * must be female sex and at least 18 years of age. * must be willing and able to complete all procedures and follow-up visits indicated in the protocol. * must have confirmed stress urinary incontinence (sui) through urodynamic studies. * must have failed two non-invasive incontinence therapies (such as behavior modification, kegel exercises, etc) for \> 3 months. exclusion criteria: * currently suffering from active urogenital infection. * has incontinence due to neurogenic causes (such as multiple sclerosis, cerebrovascular accident, spinal cord/brain injury, parkinson disease, detrusor-external sphincter dyssynergia, or similar conditions). * having concomitant pelvic floor or cystoscopic procedure. * has had prior surgical sui treatment. * has had prior radiation therapy or brachy therapy. * has an atonic bladder or post-void residual (pvr) above 100cc on two or more occasions. * is pregnant or planning to become pregnant during the study duration. * has a contraindication to therapeutic botox injections or cystoscopic procedures. * is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect urinary continence or bladder function without the sponsor's approval.

Keywords: urinary incontinence incontinence
study of bone mineral density in women with breast cancer treated with triptorelin and tamoxifen or exemestane on protocol ibcsg 25-02

Conditions: Breast Cancer; Osteoporosis

Summary: rationale: gathering information over time from bone density and laboratory tests of women with breast cancer treated with triptorelin and tamoxifen or exemestane may help the study of breast cancer in the future. purpose: this clinical trial is studying changes in bone mineral density in women with breast cancer treated with triptorelin and tamoxifen or exemestane on protocol ibc sg-25-02 (text).

objectives: * evaluate changes in bone mineral density (bmd) among premenopausal women randomized in protocol ibc sg-25202 (text-2) to receive either: a) triptorelin (gnrh analogue) for 5 years plus tamoxifen for 5 years; or b) triptorelin (gnrh analogue) for 5 years plus the steroidal aromatase inhibitor exemestane for 5 years. * evaluate serial serum markers for bone remodeling (c-telopeptide, osteocalcin, bone-specific alkaline phosphatase) and investigate their correlation with bmd. * evaluate the relationship of genetic variants of cyp19a1, erα, erß, and igf 1 with bmd. * evaluate serial serum growth factors (igf-1 and igfbp-3) and investigate whether their time course correlates with bmd. * explore the role of serum igf-1 and igfbp-3 as biomarkers of disease outcome (disease-free survival). (exploratory) outline: blood samples are collected at baseline and then periodically for 6 years. serum markers of bone remodeling and serum growth factor levels are measured. bone mineral density in the l1-l4 (postero-anterior) region of the spine and femoral neck of the hip is measured by dexa at baseline and then periodically for 6 years. any surplus serum is stored for use in unspecified future research.

Eligibility criteria:
disease characteristics: * patient must be eligible and enrolled in the text-2 trial prior to enrolling in text-bone * serial bone marrow density (bmd) measurements must be taken within the same institution * hormone receptor positive patient characteristics: * see disease characteristics * premenopausal * no bone fracture in the past 6 months that, in the investigator's judgement, could be related to bone fragility * no clinical or biochemical malabsorption syndrome, known vitamin d deficiency, active hyper- or hypoparathyroidism, or paget's disease * no uncontrolled thyroid disease, cushing disease, or other pituitary diseases * no other bone disease (including osteomalacia or osteogenesis imperfecta) prior concurrent therapy: * see disease characteristics * at least 6 months since prior and no concurrent bisphosphonate therapy (or other bone therapies such as pth or strontium) * at least 6 months since prior glucocorticoid (\> 5 mg prednisone or equivalent) for \> 1 month * at least 12 months since prior anticonvulsants

Keywords: osteoporosis estrogen receptor-positive breast cancer progesterone receptor-positive breast cancer stage ia breast cancer stage ib breast cancer stage ii breast cancer stage iiia breast cancer
brain imaging biomarkers of pathological brain aging in late-life depression

Conditions: Depression

Summary: this study investigates the relationships and differences in pet-mri brain imaging biomarkers of abnormal aging and behavioral measures in late life depression compared to healthy controls, and evaluates relationships and differences in the same imaging and behavioral measures following electroconvulsive therapy. the study tests the hypotheses that late-life depression will be associated with higher levels of accelerated aging and brain disease biomarkers, and that electroconvulsive therapy works by stimulating the reorganization of brain tissue.the data collected with contribute to improved knowledge about the neurobiology of late-life psychopathology and its treatment.

this clinical study is a combined single-center, cohort study with a (1) cross-sectional arm evaluating relationships and differences in pet-mr imaging and behavioral measures in 64 patients with late life depression (lld) compared to 64 healthy controls, and (2) a longitudinal arm evaluating relationships and differences in imaging and behavioral measures in 20 patients receiving ect as part of their normal clinical management. the study will utilise three pet tracers: (1) \[11c\]ucb-j, which targets the synaptic vesicle glycoprotein 2a receptor, to estimate synaptic density (2) \[18f\]mk-6240, which targets tau associated with neurofibrillary tangles, to assess the presence of tau pathology and (3) \[18f\]-flutemetamol, which targets beta-amyloid neuritic plaques in the brain, to assess the presence of cerebral amyloidosis. the main aim of the study is to clarify how hippocampal synaptic density, tau, amyloid and white matter lesions, relate to neuropsychological function, stress and ect in late life depression.

Eligibility criteria:
inclusion criteria: * diagnosis of late-life depression according to dsm 5 (patients only) * age over 60 years old * judged to be in good physical health by the investigator on the basis of medical history exclusion criteria: * history or evidence of psychiatric disease, as assessed by clinical interview (healthy controls only). * history of major other neurological disorder, or major internal pathology that may make him/her unfit for participation according to the interpretation by the investigator (including cardiac, lung, haematological, gastro-intestinal disorders or cancer); * current user (including ''recreational use'') of any illicit drugs,including cannabis, or has a history of drug or alcohol abuse; * had exposure to ionizing radiation (\> 1 msv) in other research studies within the last 12 months; * has a contra-indication for mri scanning; * suffers from claustrophobia or cannot tolerate confinement during pet-mri scanning procedures; cannot lie still for 60 minutes inside the scanner; * does not understand the study procedures * unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator; * underwent ect within the last 3 months before enrollment (patients)

Keywords: late-life depression electroconvulsive therapy neuroimaging aging
immunoadsorption and immunoglobulin substitution for heart failure after myocardial infarction

Conditions: Heart Failure; Coronary Heart Disease

Summary: the purpose of this study is to investigate, if immunoadsorption of autoantibodies with subsequent substitution of immunoglobulins is able to improve cardiac function of patients with heart failure after myocardial infarction and presence of cardiac autoantibodies.

heart failure due to coronary heart disease (chd) remains one of the most frequent causes of death. left-ventricular ejection fraction \ 70%. therefore, new strategies and therapies towards treatment of heart failure are needed. heart failure due to left ventricular dysfunction can develop in chd beyond the area of myocardial infarction. some of these patients develop myocardial autoantibodies, which have been shown to exert a negative inotropic effect. their elimination by immunoadsorption has been shown to improve left ventricular function in dilatative cardiomyopathy. immunoglobulins are substituted to minimize infection risk at a level, which has been shown not to effect cardiac function. this intervention might also ameliorate cardiac function in patients with heart failure due to other origins. this study therefore aims to evaluate the effect of immunoadsorption with subsequent immunoglobulin substitution.

Eligibility criteria:
inclusion criteria: * heart failure and known coronary heart disease / post myocardial infarction * completed treatment for coronary heart disease (no known hemodynamically effective stenosis in coronary vessels) * evidence of scarred myocardial tissue in low-dose stress echocardiography or myocardial scintigraphy or mri * evidence of hypo-contractile myocardium in echocardiography or mri outside of infarction area * at least 3 months without acute coronary syndrome or coronary intervention * left-ventricular ejection fraction by echocardiography \< 45% * detection of at least one myocardial autoantibody (e.g. anti-ß1-receptor, anti-tni, anti-kchip2) in serum * dyspnea on exertion equivalent to nyha ii - nyha iv * written informed consent of the patient exclusion criteria: * heart failure due to other cardiac disease (e.g. dilatative cardiomyopathy without evidence of chd, primary valve defects \> ii°, toxic cardiomyopathy) * active infection * pregnancy * malign tumor disease * other secondary disease with life expectancy \< 1 year * refusal by the patient

Keywords: heart failure coronary heart disease autoantibodies immunoadsorption immunoglobulin substitution
'fibrosis in the lost hepatitis c population - track, trace and treat'

Conditions: Chronic Hepatitis c

Summary: objective: to coordinate active tracing of chronic hepatitis c patients lost to follow-up to inform them about there disease severity and treatment options. study design: this is a prospective cohort study, which will start as a pilot study in the radboudumc population: lost to follow-up chronic hepatitis c patients in the region nijmegen. this so-called lost population consists of all patients, that in the past have been identified at the radboudumc but who are currently lost to or have been withdrawn from follow-up. the time-span of interest will be 2000-2015. we estimate that this project will retrace 100 lost patients through this search.


Eligibility criteria:
inclusion criteria: * ever diagnosed with hepatitis c, lost to follow-up exclusion criteria: * none
the effect of therapeutic touch to mothers with preterm babies

Conditions: Therapeutic Touch

Summary: the study was carried to determine the effect of yakson or gentle human touch methods applied by the mothers to their preterm newborns on mother's attachment level and baby's response.

the study was carried out as a randomized controlled experimental research. population of the study is all of the babies who were hospitalized at the neonatal intensive care unit of a state hospital in turkey between august 2016 and august 2017 and the mothers of the babies; its sample is 90 mothers and their babies included with randomization method who were matching the criteria who were also hospitalized between these dates.

Eligibility criteria:
inclusion criteria: mothers' selection criteria * mother should not have any defines psychiatric diseases, * mother should not have any physical disabilities, * mother should be literate and open to communication, * should not have transportation problem, * should be willing to participate and volunteer for the study. babies' selection criteria * babies should be between 26-34 gestation weeks, * should not have congenital abnormalities, * babies should not have any health problems that may hinder the practice (intracranial hemorrhage, sepsis, hemorrhagic diseases, having an operation, etc.). exclusion criteria: -participants must have inclusion criterias.

Keywords: therapeutic touch yakson gentle human touch maternal attachment preterm baby
supplemental oxygen and complications after abdominal surgery (the proxi-trial)

Conditions: Laparotomy

Summary: aim: to investigate the effect of high intra- and postoperative oxygen concentration (80%, as opposed to normally 30%) on surgical wound infection and pulmonary complications after abdominal surgery. background: surgical wound infection is a common and serious complication. tissue oxygen tension is often low after surgery and the resistance against infection depends on this factor through bacterial killing by neutrophils. oxygen is a substrate in this reaction, and it is hypothesized that by increasing the arterial oxygen tension, the risk of surgical wound infection is reduced. previous studies to test this hypothesis have shown entirely different results. hence, the clinical decision between high and normal oxygen concentration is still controversial. primary hypothesis of study: use of 80% oxygen decreases the incidence of surgical wound infection after abdominal surgery. secondary objectives: to investigate the effect 80% oxygen on pulmonary complications (atelectasis, pneumonia, respiratory insufficiency), second operation, mortality and length of postoperative hospitalization and admission to intensive care unit after abdominal surgery.


Eligibility criteria:
inclusion criteria: * age 18 years or older. * laparotomy, acute or elective. in case of gynaecological surgery only if malignancy is suspected (defined as risk of ovarian malignancy index \>200 or a specimen with atypical or neoplastic cells). exclusion criteria: * other surgery within 30 days (except surgery in local anaesthesia). * chemotherapy within 3 months. * inability to give informed consent. * inability to keep oxygen saturation above 90% without supplemental oxygen (measured preoperatively by pulse oximetry).
safety, tolerability, and pharmacokinetics of single and multiple doses of biib033 in healthy japanese participants

Conditions: Central Nervous System (CNS) Demyelinating Disease; Multiple Sclerosis

Summary: the primary objective of this study is to assess the safety and tolerability of a single dose and multiple doses of biib033 administered to healthy adult japanese participants. the secondary objectives of this study are to evaluate the pharmacokinetics (pk) profile of biib033 administered as single and multiple doses in healthy adult japanese participants and to assess the single-dose and multiple-dose immunogenicity of biib033.


Eligibility criteria:
key inclusion criteria: * japanese subjects must have been born in japan, and their biological parents and grandparents must all have been of japanese origin. * subjects who have lived out of japan for more than 5 years must not have significantly modified their diets since leaving japan. * must be a nonsmoker or light smoker (\<10 cigarettes per day) and be willing to abstain from using tobacco and tobacco-containing products during the inpatient period and for at least 48 hours prior to day -1, day 14 (for cohort 3), and all outpatient visits. * must have a body mass index of 18 to 32 kg/m2, inclusive. key exclusion criteria: * history of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the investigator. * serious infection (e.g., pneumonia, septicemia) as determined by the investigator within the 3 months prior to day -1. * fever or bacterial or viral infection (including upper respiratory tract infection) within 2 weeks prior to day -1. * history of severe allergic or anaphylactic reactions. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: japanese single ascending dose (sad) multiple ascending dose (mad)
multimedia aid gynecologic counseling and consent

Conditions: Endometrium Cancer; Sentinel Lymph Node; Perioperative/Postoperative Complications

Summary: this is an interventional trial to introduce two short animated videos into preoperative counseling/consent and to compare patient comprehension and satisfaction with a multimedia approach compared to standard of care currently. the investigators anticipate that patients will retain more information about their surgery and peri-operative care and will be more satisfied with a multimedia approach.

the investigators plan a pilot study where patients will be randomized to receiving standard consent and teaching prior to their planned surgery for endometrial cancer or standard consent and multimedia video aid with targeted teaching. this video will be an adjunct to the standard consent process and supplement the pre and post-operative teaching that is currently not formalized. the primary outcome is patient satisfaction. the secondary outcomes include patient understanding and physician satisfaction. the investigators hypothesize that patients will be more satisfied when their consent for surgery is done in conjunction with this multimedia aid.

Eligibility criteria:
inclusion criteria: * english-speaking * has diagnosis of endometrial cancer * planned minimally invasive surgical treatment with hysterectomy and sentinel lymph node biopsy exclusion criteria: * non-english speaking * pregnant

Keywords: multimedia, video teaching
a study of famitinib in patients with advanced metastatic renal cell cancer

Conditions: Renal Cell Cancer; Metastatic Renal Cell Cancer

Summary: * famitinib is a tyrosin-inhibitor agent targeting at c-kit, vegfr2, pdgfr, vegfr3, flt1 and flt3. phase i study has shown that the toxicity is manageable. * the purpose of this study is to compare the efficacy and safety profile between famitinib and sunitinib in patients with metastatic renal cell carcinoma.


Eligibility criteria:
inclusion criteria: * patients with histologically confirmed advanced renal cell carcinoma including clear cell component and not available for surgery * first-line therapy or second-line treatment (second-line treatment e.g chemotherapy or cytokine therapy as first-line treatment failure or resistant patients) * with measurable disease (using recist1.0 standard conventional ct scan ≥ 20 mm, spiral ct scan ≥ 10mm, target lesion did not receive radiation therapy, cryotherapy) * male or female, age ≥18 and ≤75 * ecog 0-1 * life expectancy ≥ 3 months * subjects received surgery, chemotherapy, radiation therapy, cytokines treatment caused the damage has been restored, the time interval ≥ 4 weeks, and the wound has completely healed * normal major organ function * signed and dated informed consent exclusion criteria: * previously received targeted therapy of the metastatic renal cell carcinoma (such as sunitinib, sorafenib) * past or suffering from other cancer, but other than cure basal cell carcinoma and cervical carcinoma in situ * participated in other clinical trials within four weeks * a variety of factors that affect the oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction) * known brain metastases, spinal cord compression, cancer, meningitis, or screening ct or mri examination revealed brain or leptomeningeal disease * patients with hypertension (systolic blood pressure\> 140 mmhg, diastolic blood pressure\> 90 mmhg). patients with more than class i, myocardial ischemia or myocardial infarction, arrhythmia (including qt interval ≥ 440ms) and class i heart failure. * urine protein ≥ + + and confirmed the 24-hour urinary protein\>1.0 g * coagulopathy with bleeding tendency (such as active peptic ulcer) or are receiving thrombolytic or anticoagulant therapy * previous hyperactivity / venous thromboembolic events, such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis and pulmonary embolism * the preexisting abnormal thyroid function, even in the case of medication still can not be maintained within the normal range * with a history of abuse of psychotropic drugs or mental disorders * patients with hepatitis b or hepatitis c * history of immunodeficiency, including hiv testing positive or suffering from acquired, congenital immunodeficiency disease, or a history of organ transplantation

Keywords: mrcc metastatic renal cell cancer famitinib sunitinib
hx575 epoetin alfa subcutaneously (s.c.) in chronic kidney disease (ckd)

Conditions: Chronic Kidney Disease

Summary: the study will assess the immunogenicity, safety, and efficacy of hx575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (ckd)


Eligibility criteria:
main inclusion criteria: * adult male and female patients w or w/o dialysis treatment * stable i.v. or s.c. maintenance therapy with an eu-approved esa treatment or esa naïve. * adequate iron substitution main exclusion criteria: * history of pure red cell aplasia (prca) or anti-erythropoietin (epo) antibodies * contraindications for esa therapy * serum albumin \< 3.0 g/dl * immunocompromized patients (immunosuppressive treatment, chemotherapy) * hepatitis c infection on an active treatment or hepatitis b or human immunodeficiency virus (hiv) infection * systemic lupus erythematosus * symptomatic congestive heart failure, unstable angina pectoris, or myocardial infarction within 6 months * history of malignancy of any organ system within the last 5 years * history of use of any non-eu approved esa

Keywords: epoetin alfa, esa, hx575, ckd